Phase 4
Completed N=6
Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
Bariatric Surgery Candidate
Source: ClinicalTrials.gov NCT03424239 ↗
Enrolled (actual)
6
Serious AEs
25.0%
Results posted
Apr 2021
Primary outcomePrimary: Change in Serum CTX — 0.228 ng/ml
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study evaluates whether zoledronic acid can prevent the high bone turnover that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum CTX |
0.228 | — |
| SECONDARY Change in Total Hip Bone Mineral Density by DXA |
-0.039 | — |
| SECONDARY Change in Trabecular Spine Bone Mineral Density by QCT |
4.9 | — |
| SECONDARY Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0 |
— | — |
| SECONDARY Change From Baseline of Femoral Neck Bone Density Measured by DXA |
-0.038 | — |
| SECONDARY Change From Baseline of Spine Bone Density Measured by DXA |
0.003 | — |
Eligibility Criteria
Inclusion Criteria
- Men must be age ≥ 50
- Women must be age ≥ 25 and postmenopausal
- Planning to receive RYGB or SG surgery
Exclusion Criteria
- Age < 25
- Prior bariatric surgery
- Weight ≥ 400 lbs
- Liver or renal disease
- Hypercalcemia, hypocalcemia, or hypomagnesemia
- Serum 25-hydroxyvitamin D < 20 ng/mL
- History of bone-modifying disorders
- Use of bone-active medications
- Known sensitivity to bisphosphonates
- Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 6 months
Data sourced from ClinicalTrials.gov (NCT03424239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.